Z-1591-2024Class II

Identity Imprint PS Tibial Tray Size 4: Lot 540287

Name: Z-1591-2024 Identity Imprint PS Tibial Tray Size 4: Lot 540287
Creator: Conformis, Inc.
Published: 2024-03-11
License: https://open.fda.gov/license/

ConforMIS, Inc. / initiated 2024-03-11 / Open, Classified / root cause: manufacturing process

FDA source

Conformis, Inc. began a recall of Identity Imprint PS Tibial Tray Size 4: Lot 540287 on 2024-03-11. FDA classified it as Class II and gives the reason as "Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1591-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-11
Posted: 2024-04-17
Recalling firm: ConforMIS, Inc.
Product: Identity Imprint PS Tibial Tray Size 4: Lot 540287
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On March 22, 2024 customers were sent URGENT MEDICAL DEVICE FIELD ACTION letters via email. Customers were provided the following instructions: Conformis is seeking the return of the devices in boxes marked with Lot 508287 or Lot 540827. This is the only lot that was distributed. Our records indicate you are the recipient of one of the affected Lot. If you have not already, please return the device using the provided FEDEX label. Additionally, return page 2 of this letter to acknowledge receipt of this notification. Please read, complete, and sign page 2 of this letter. If you have any questions please contact myself or another Conformis representative. If you have an urgent question, please call customer service 781 345 9001.
Quantity in commerce: 3 units
Distribution: US Nationwide distribution in the states of FL, KS and NH.
Product codes and lots: Catalog Number: TPS-301-T04S; UDI#: M572TPS301T04S011, Lot number 540287

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1591-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1591-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-17

Product code JWH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)